Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: A phase II study based on surgical reassessment
The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal ca...
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| Published in: | Gynecologic oncology Vol. 119; no. 3; pp. 451 - 456 |
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| Main Authors: | , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
United States
Elsevier Inc
01.12.2010
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| ISSN: | 0090-8258, 1095-6859, 1095-6859 |
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| Abstract | The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC).
Patients with stage III–IV OFPC initiated treatment within 12
weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175
mg/m
2) and carboplatin (AUC 6) every 3
weeks for up to 6 cycles, plus oral erlotinib 150
mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1
cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1
cm residual disease) using a two-stage design (alpha
=
0.10, beta
=
0.10).
The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum.
Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III–IV OFPC. |
|---|---|
| AbstractList | The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC).BACKGROUNDThe purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC).Patients with stage III-IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m²) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1cm residual disease) using a two-stage design (alpha=0.10, beta=0.10).METHODSPatients with stage III-IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m²) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1cm residual disease) using a two-stage design (alpha=0.10, beta=0.10).The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum.RESULTSThe study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum.Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III-IV OFPC.CONCLUSIONSAmong unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III-IV OFPC. The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC). Patients with stage III–IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m 2) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1 cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1 cm residual disease) using a two-stage design (alpha = 0.10, beta = 0.10). The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum. Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III–IV OFPC. Abstract Background The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC). Methods Patients with stage III–IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m2 ) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1 cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1 cm residual disease) using a two-stage design (alpha = 0.10, beta = 0.10). Results The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum. Conclusions Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III–IV OFPC. The purpose of this study was to determine whether adding the anti-epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor erlotinib to carboplatin/paclitaxel improved pathologic complete response (pCR) at reassessment surgery in epithelial ovarian, fallopian tube, or primary peritoneal cancers (OFPC). Patients with stage III-IV OFPC initiated treatment within 12 weeks of initial cytoreductive surgery or, after histologic confirmation of diagnosis, neoadjuvantly. Treatment included paclitaxel (175 mg/m²) and carboplatin (AUC 6) every 3 weeks for up to 6 cycles, plus oral erlotinib 150 mg daily. The primary objective was to determine whether the pCR rate at reassessment surgery was at least 60% after optimal cytoreduction at initial surgery (< 1cm residual disease), or at least 40% after suboptimal cytoreduction (at least 1cm residual disease) using a two-stage design (alpha=0.10, beta=0.10). The study population included 56 patients with stage III-IV OFPC. EGFR gene amplification was present in 15% of the 20 tumors evaluated. Twenty-eight patients had protocol therapy after optimal cytoreduction (stratum I), 23 had protocol therapy either after suboptimal cytoreduction (stratum II), and 5 received neoadjuvant therapy prior to cytoreduction (stratum III). Pathologic CR was confirmed in 8 patients (29%; 95% confidence intervals 13%, 49%) in stratum I and 3 patients (11%, 95% C.I. 2%, 28%) in stratum II, which did not meet the prespecified efficacy endpoint in either stratum. Among unselected patients, erlotinib plus carboplatin-paclitaxel did not improve pCR rates compared with historical experience with carboplatin-paclitaxel alone in patients with stage III-IV OFPC. |
| Author | Christos, Paul Runowicz, Carolyn D. Chen, Helen X. Blank, Stephanie V. Sparano, Joseph A. Muggia, Franco M. Liebes, Leonard Curtin, John P. Goldman, Noah |
| AuthorAffiliation | 1 Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY 2 Division of Biostatistics and Epidemiology, Department of Public Health, Weill Medical College of Cornell University, New York, NY 5 Division of Medical Oncology, Department of Medicine, New York University School of Medicine, New York, NY 4 Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY 3 Division of Gynecologic Oncology, Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington, CT 6 Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD |
| AuthorAffiliation_xml | – name: 5 Division of Medical Oncology, Department of Medicine, New York University School of Medicine, New York, NY – name: 1 Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY – name: 3 Division of Gynecologic Oncology, Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington, CT – name: 4 Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY – name: 2 Division of Biostatistics and Epidemiology, Department of Public Health, Weill Medical College of Cornell University, New York, NY – name: 6 Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD |
| Author_xml | – sequence: 1 givenname: Stephanie V. surname: Blank fullname: Blank, Stephanie V. organization: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA – sequence: 2 givenname: Paul surname: Christos fullname: Christos, Paul organization: Division of Biostatistics and Epidemiology, Department of Public Health, Weill Medical College of Cornell University, New York, NY, USA – sequence: 3 givenname: John P. surname: Curtin fullname: Curtin, John P. organization: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA – sequence: 4 givenname: Noah surname: Goldman fullname: Goldman, Noah organization: Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, NY, USA – sequence: 5 givenname: Carolyn D. surname: Runowicz fullname: Runowicz, Carolyn D. organization: Division of Gynecologic Oncology, Neag Comprehensive Cancer Center, University of Connecticut Health Center, Farmington, CT, USA – sequence: 6 givenname: Joseph A. surname: Sparano fullname: Sparano, Joseph A. email: jsparano@montefiore.org organization: Department of Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, USA – sequence: 7 givenname: Leonard surname: Liebes fullname: Liebes, Leonard organization: Division of Medical Oncology, Department of Medicine, New York University School of Medicine, New York, NY, USA – sequence: 8 givenname: Helen X. surname: Chen fullname: Chen, Helen X. organization: Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD, USA – sequence: 9 givenname: Franco M. surname: Muggia fullname: Muggia, Franco M. organization: Division of Medical Oncology, Department of Medicine, New York University School of Medicine, New York, NY, USA |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/20837357$$D View this record in MEDLINE/PubMed |
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| Keywords | Carboplatin Reassessment surgery Erlotinib Paclitaxel Ovarian cancer |
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| SubjectTerms | Adult Aged Antineoplastic Combined Chemotherapy Protocols - adverse effects Antineoplastic Combined Chemotherapy Protocols - therapeutic use Carboplatin Carboplatin - administration & dosage Carboplatin - adverse effects Chemotherapy, Adjuvant Disease-Free Survival ErbB Receptors - antagonists & inhibitors ErbB Receptors - genetics Erlotinib Erlotinib Hydrochloride Fallopian Tube Neoplasms - drug therapy Fallopian Tube Neoplasms - genetics Fallopian Tube Neoplasms - pathology Fallopian Tube Neoplasms - surgery Female Gene Amplification - drug effects Genes, erbB-1 - drug effects Hematology, Oncology and Palliative Medicine Humans Middle Aged Neoadjuvant Therapy Neoplasm Staging Obstetrics and Gynecology Ovarian cancer Ovarian Neoplasms - drug therapy Ovarian Neoplasms - genetics Ovarian Neoplasms - pathology Ovarian Neoplasms - surgery Paclitaxel Paclitaxel - administration & dosage Paclitaxel - adverse effects Peritoneal Neoplasms - drug therapy Peritoneal Neoplasms - genetics Peritoneal Neoplasms - pathology Peritoneal Neoplasms - surgery Quinazolines - administration & dosage Quinazolines - adverse effects Reassessment surgery Young Adult |
| Title | Erlotinib added to carboplatin and paclitaxel as first-line treatment of ovarian cancer: A phase II study based on surgical reassessment |
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